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Additional limitations include toxicity, developed resistance, and the effect of the potentiator compound on the host cell

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According to the American Society for Dermatologic Surgery, the FDA proposed an OTC ban way back in 2006, recommending more studies by the National Toxicology Program (NTP) due to as-yet-unproven concerns that it may cause cancer, as well as concerns over ochronosisskin darkening (in other words, the opposite of what most hydroquinone users are going for)